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Director Validation Jobs in Raleigh, NC (NOW HIRING)

CAI

Validation Engineer

Raleigh, NC

$72K - $80K/yr

... work - Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or equivalent experience) - 2-4 years ...

CAI

Validation Engineer

Raleigh, NC

... work - Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or equivalent experience) - 2-4 years ...

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Director Validation information

What are the typical daily responsibilities of a Director Validation in a regulated industry?

A Director Validation typically oversees the planning, execution, and review of validation projects to ensure compliance with regulatory requirements. Daily responsibilities include leading teams, reviewing validation protocols and reports, coordinating with quality, engineering, and regulatory departments, and addressing any deviations or issues that arise during validation activities. The role may also involve direct communication with regulatory agencies during audits and inspections. This ensures products or processes meet the highest standards of quality and regulatory compliance, ultimately supporting the company’s overall operational success.

What does a Director of Validation do?

A Director of Validation oversees the validation processes in industries like pharmaceuticals, biotechnology, or medical devices to ensure compliance with regulatory standards. They develop and implement validation strategies for equipment, processes, and systems, ensuring they meet quality and safety requirements. This role involves managing validation teams, coordinating with regulatory bodies, and maintaining documentation to support audits and inspections. The Director also ensures adherence to industry guidelines such as FDA, EMA, or ISO standards.

What are the key skills and qualifications needed to thrive in the Director Validation position, and why are they important?

To thrive as a Director Validation, you need extensive experience in validation processes, regulatory compliance, quality assurance, and a relevant scientific or engineering degree. Familiarity with industry standards, validation lifecycle management software, and certifications such as Six Sigma or PMP are highly valued. Strong leadership, strategic thinking, and excellent communication skills help to drive complex projects and foster cross-functional collaboration. These skills are vital to ensuring validated processes meet regulatory standards and support organizational goals efficiently.

What are the most commonly searched types of Validation jobs in Raleigh, NC? The most popular types of Validation jobs in Raleigh, NC are:
What are popular job titles related to Director Validation jobs in Raleigh, NC? For Director Validation jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Director Validation jobs in Raleigh, NC look for? The top searched job categories for Director Validation jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Director Validation jobs? Cities near Raleigh, NC with the most Director Validation job openings:
Director Validation jobs near you
Infographic showing various Director Validation job openings in Raleigh, NC as of June 2026, with employment types broken down into 1% As Needed, 90% Full Time, 7% Part Time, 1% Temporary, and 1% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution.
Validation Engineer II

Validation Engineer II

Alcami Corporation

Morrisville, NC • On-site

Full-time

Posted 20 days ago

Key responsibilities

  • Create and execute validation protocols, procedures, and final reports for environmental chambers and related equipment.

  • Perform pre- and post-validation verification and incidental calibrations on test equipment including controllers, gauges, and recorders.

  • Independently manage technical writing, documentation, and peer review of validation reports, and interface with customers to resolve deviations.

Alcami rating

7.3

Company rating: 7.3 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

Job description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?


Responsibilities for a Validation Engineer II involve validation equipment preparation, protocol execution, and final report generation. This position will perform a wide range of validation activities focused on environmental chambers, including: cryo-freezers, cold rooms, refrigerators, incubators, depyrogenation ovens, stability chambers and warehouses, as well as sterilizers and CSV. Interface with customers and equipment end users. The Validation Engineer II works with minimal supervision and will independently work at customer sites with small and medium projects.


  • 100% on-site position.
  • 1st Shift: Monday - Friday, 8:00am - 4:30pm.
  • This position is for day shift but may require some occasional off shift and/or weekend coverage to accommodate schedules and/or project timelines.

  • Perform pre- and post-validation verification on test equipment.
  • Perform calibrations incidental to validation including controllers, gauges, recorders, etc.
  • Create and execute validation protocols, procedures, and final reports; perform validation projects.
  • Perform peer review of validation reports.
  • Learn and execute troubleshooting strategies in the field.
  • Independently manage technical writing and documentation aspects of validation reports.
  • Write and work with clients to resolve deviations.
  • Maintain records of pertinent information for the project including project costs reconciliation.
  • Relay opinions or interpretations of results to customer.
  • Other duties as assigned.

  • BA/BS in technical or science related field of study. Candidates with an HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience.
  • Minimum of two years of direct validation experience.

  • Experience with validation of temperature-controlled units and temperature mapping.
  • Ability to perform tasks with high standard of quality and accuracy.
  • Spreadsheet and word processing applications experience, computer literacy.
  • Strong written and verbal communication skills.
  • Proficient with test instruments.
  • ISO 9001, ISO 17025, GMP and GLP knowledge.

  • Up to 80% travel expected. This position includes travel during the day to client sites.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly stand, walk, and use hands, frequently reach, stoop, kneel, crouch or crawl and talk or hear, and occasionally sit and climb or balance. In this role, you will frequently work in an office, lab or at customer sites and be exposed to extreme cold (non-weather). You will occasionally be exposed to wet or humid conditions, work near moving mechanical parts, work in high places, near toxic or caustic chemicals, in outdoor weather conditions and exposure to vibration. The noise level that is typical for this position is loud.

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